In light of the findings and recommendations of the external evaluation conducted by an expert panel at the Reagan-Udall Foundation (summarized here), FDA Commissioner Califf announced a proposed redesign to create the FDA Human Foods Program.

Under the proposed redesign, the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR), and certain functions of the Office of Regulatory Affairs (ORA) will be unified into a new organization called the Human Foods Program, which will be overseen by a Deputy Commissioner for Human Foods. The Deputy Commissioner will report directly to the FDA Commissioner and will be charged with “leading a unified Human Foods Program that keeps the foods we regulate safe and nutritious, while ensuring the agency remains on the cutting edge of the latest advancements in science, technology, and nutrition.” The Deputy Commissioner will have authority over policy, strategy, and regulatory program activities within the Program, as well as resource allocation and risk-prioritization. FDA is currently recruiting for the new Deputy Commissioner of the Human Foods Program. FDA’s visual depictions of the reorganization are provided below.

The proposed new Human Foods Program will also include

• (1) The creation of a Center for Excellence in Nutrition to help consumers make more informed food choices. The Office of Critical Foods, which will be responsible for foods like infant formula and medical foods as directed by the 2023 Consolidated Appropriations Act, will fall within the Center for Excellence in Nutrition.

• (2) The establishment of an Office of Integrated Food Safety System Partnerships to focus on coordinating and integrating the FDA’s food safety and response activities with state and local regulatory partners to meet the vision of an Integrated Food Safety System, as per FSMA.

Additionally, a Human Foods Advisory Committee will be established to help support the Agency and will consist of external experts to advise on challenging and emerging issues in food safety, nutrition, and innovative food technologies.

As for ORA, its operating structure will be transformed into an enterprise-wide organization that supports the Human Foods Program and all other FDA regulatory programs which will allow ORA to be focused on inspections, laboratory testing, import, and investigative operations.

As stated in the announcement, the next step will be for FDA to develop the vision into a concrete reorganizational proposal in close coordination with external stakeholders. The development of a detailed plan and the execution of the proposed redesign will be led by a recently formed Implementation and Change Management Group. As the redesign continues to take shape, CFSAN, ORA, and OFPR will continue to operate under their current structures with direct oversight by the FDA Commissioner.